GMP Operational Quality Sr Specialist jobs in United States
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JMD Technologies Inc. · 1 day ago

GMP Operational Quality Sr Specialist

JMD Technologies Inc. is seeking a GMP Operational Quality Senior Specialist to join their QA team in the Cell & Gene Therapy space. This role provides GMP operational support across clinical and commercial manufacturing, ensuring quality oversight and compliance while collaborating with cross-functional teams.

Information Technology & Services
Hiring Manager
Shravan Jaisswal
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Responsibilities

QA operational support for GMP manufacturing (clinical & commercial drug product)
Batch record review, batch disposition, and QA data review
Deviations, investigations, CAPAs, OOS/OOT management
Quality on the Floor support, walkthroughs, and manufacturing document review
Support product release, COAs, change controls, and inspection readiness
Cross-functional collaboration with Manufacturing, QC, Engineering, and Supply Chain
Participate in process improvements and inspection readiness initiatives
Provide guidance for product complaints, recalls, and compliance gaps

Qualification

GMP OperationsBatch Record ReviewDeviations ManagementCell & Gene TherapyTrackWiseAseptic ProcessingCAPAsOOS/OOT ManagementOracleCross-Functional Leadership

Required

Strong QA Operations background in a GMP environment
Experience with batch record review, batch disposition, or product release
Hands-on experience with deviations, investigations, CAPAs, and OOS/OOT
Knowledge of GMP, aseptic processing, and CMC regulatory requirements
Experience with TrackWise, Oracle, or similar QA/ERP systems
Master's degree with 2–3 years relevant experience, or Bachelor's degree with 3–5 years experience
Comfortable working fully onsite and supporting production floor activities
Demonstrated success leading cross-functional teams

Preferred

Exposure to Cell & Gene Therapy or ATMP manufacturing

Company

JMD Technologies Inc.

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JMD Technologies Staffing, Recruitment and RPO service company managed with leaders having 21+ years of experience in the industry.

Funding

Current Stage
Early Stage
Company data provided by crunchbase